search
Back to results

Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors

Primary Purpose

HIV Infections, Cervix, Dysplasia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Isotretinoin
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Cervix Dysplasia, Cervix Diseases, Isotretinoin, Cervical Intraepithelial Neoplasia, Cervix Neoplasms, Keratolytic Agents

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria You may be eligible for this study if you: Are an HIV-positive female. Are at least 13 years old. (Need consent of parent or guardian if under 18.) Have cervical tumors, as determined by a biopsy performed by a doctor. Agree to use both condoms and the pill during the study. Exclusion Criteria You will not be eligible for this study if you: Have received certain cancer therapies (such as chemotherapy) within the past 3 or 4 months. Have had a hysterectomy (uterus removed) within the past 4 months. Are taking tetracycline or Vitamin A. Have taken certain medications. (Approved anti-HIV drugs and medications to prevent AIDS-related opportunistic infections are okay.) Are pregnant.

Sites / Locations

  • Alabama Therapeutics CRS
  • USC CRS
  • UCLA CARE Center CRS
  • Usc La Nichd Crs
  • Ucsd, Avrc Crs
  • Ucsf Aids Crs
  • Santa Clara Valley Med. Ctr.
  • San Mateo County AIDS Program
  • Howard University Hosp., Div. of Infectious Diseases, ACTU
  • South Florida CDC Ft Lauderdale NICHD CRS
  • Univ. of Florida Jacksonville NICHD CRS
  • Univ. of Miami AIDS CRS
  • Univ. of Hawaii at Manoa, Leahi Hosp.
  • Northwestern University CRS
  • Rush Univ. Med. Ctr. ACTG CRS
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
  • Tulane/LSU Maternal/Child CRS
  • Johns Hopkins Adult AIDS CRS
  • Bmc Actg Crs
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Washington U CRS
  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
  • NJ Med. School CRS
  • SUNY - Buffalo, Erie County Medical Ctr.
  • Beth Israel Med. Ctr. (Mt. Sinai)
  • NY Univ. HIV/AIDS CRS
  • Memorial Sloan-Kettering Cancer Ctr.
  • Univ. of Rochester ACTG CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • Unc Aids Crs
  • Duke Univ. Med. Ctr. Adult CRS
  • The Ohio State Univ. AIDS CRS
  • Hosp. of the Univ. of Pennsylvania CRS
  • University of Washington AIDS CRS
  • UW School of Medicine - CHRMC
  • Puerto Rico-AIDS CRS
  • San Juan City Hosp. PR NICHD CRS
  • Mbeya Med. Research Program, Mbeya Referral Hosp. CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001073
Brief Title
Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors
Official Title
A Randomized Phase III Trial of Oral Isotretinoin Versus Observation for Low-Grade Squamous Intraepithelial Lesions in HIV-Infected Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if it is safe and effective to give isotretinoin to HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous. Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected women are at a greater risk, and often their tumors become cancerous more quickly than those in HIV-negative women. Isotretinoin may be able to prevent this from happening. However, since these tumors tend to disappear over time, many doctors are hesitant to give their patients isotretinoin since this drug causes birth defects. This study looks at whether it is better to treat cervical tumors in HIV-infected women or to wait and see if they will disappear by themselves.
Detailed Description
Cervical neoplasia is frequently seen in HIV-infected women, apparently resulting from immunosuppression and common risk factors, including sexual behavior patterns. In HIV seronegative women, progression of preinvasive neoplasia is relatively slow, and up to 40 percent of low grade squamous intraepithelial lesions (grade I CIN/HPV-associated changes) regress to a normal appearance over time. Many clinicians have opted not to treat CIN I/HPV-associated changes due to this high spontaneous regression rate. Currently, retinoids, principally isotretinoin, are the most consistently effective medical therapy for CIN/HPV-associated changes, but use of isotretinoin in HIV-infected patients has not been extensively documented. (AS PER AMENDMENT 6/10/97) Patients are randomized to receive oral isotretinoin for 6 months or be observed only for 6 months, with 12 additional months of follow-up. [AS PER AMENDMENT 7/23/99: Follow-up time has been decreased to 9 months from the last patient enrolled.]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cervix, Dysplasia
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Cervix Dysplasia, Cervix Diseases, Isotretinoin, Cervical Intraepithelial Neoplasia, Cervix Neoplasms, Keratolytic Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Isotretinoin

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are an HIV-positive female. Are at least 13 years old. (Need consent of parent or guardian if under 18.) Have cervical tumors, as determined by a biopsy performed by a doctor. Agree to use both condoms and the pill during the study. Exclusion Criteria You will not be eligible for this study if you: Have received certain cancer therapies (such as chemotherapy) within the past 3 or 4 months. Have had a hysterectomy (uterus removed) within the past 4 months. Are taking tetracycline or Vitamin A. Have taken certain medications. (Approved anti-HIV drugs and medications to prevent AIDS-related opportunistic infections are okay.) Are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Robinson
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mitchell Maiman
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Therapeutics CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Ucsd, Avrc Crs
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
Country
United States
Facility Name
Santa Clara Valley Med. Ctr.
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
San Mateo County AIDS Program
City
San Mateo
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Howard University Hosp., Div. of Infectious Diseases, ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20059
Country
United States
Facility Name
South Florida CDC Ft Lauderdale NICHD CRS
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Univ. of Hawaii at Manoa, Leahi Hosp.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Bmc Actg Crs
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
NJ Med. School CRS
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
SUNY - Buffalo, Erie County Medical Ctr.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Duke Univ. Med. Ctr. Adult CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Ohio State Univ. AIDS CRS
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
UW School of Medicine - CHRMC
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Puerto Rico-AIDS CRS
City
San Juan
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
Country
Puerto Rico
Facility Name
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
City
Mbeya
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
8880203
Citation
Robinson WR, Morris CB. Cervical neoplasia. Pathogenesis, diagnosis, and management. Hematol Oncol Clin North Am. 1996 Oct;10(5):1163-76. doi: 10.1016/s0889-8588(05)70391-9.
Results Reference
background

Learn more about this trial

Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors

We'll reach out to this number within 24 hrs